MAUDE manufacturer profile
CARL ZEISS MEDITEC AG (JENA) · OTL
MAUDE profile for Femtosecond Laser System For Refractive Correction
Key facts
| Manufacturer | CARL ZEISS MEDITEC AG (JENA) |
|---|---|
| Manufacturer group | CARL ZEISS MEDITEC AG (JENA) |
| Product code | OTL |
| Product code name | Femtosecond Laser System For Refractive Correction |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Visual Impairment, Adverse Event Without Identified Device or Use Problem, Halo, Dry Eye(s), Blurred Vision, Loss of Vision, Insufficient Information, Use of Device Problem Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1